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Time Limited Eating in Adolescents (Time LEAd): a Pilot Study

NCT03954223 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2024-03-04

Study results available
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Summary

The investigators propose a randomized controlled trial in 90 children (age 13-21y) with obesity recruited from clinical programs at the Children's Hospital Los Angeles (CHLA). Patients will be randomized to one of three treatment groups for a 12-week intervention: Group 1) Low sugar and carbohydrate diet (LSC, \<90 gm carbohydrate (CHO)/day, \<25 gm added sugar/day) + blinded CGM (used to monitor adherence and glycemic outcomes without real time feedback). Group 2) LSC+TLE (16-hour fast/8-hour feed for 3 days per week) + blinded CGM, Group 3) LSC+TLE+ real time feedback via CGM (to evaluate effect of providing CGM data on intervention efficacy).

Conditions

  • Obesity, Childhood

Interventions

BEHAVIORAL

Low sugar and carbohydrate diet

Low sugar and carbohydrate diet (LSC, \<90 gm carbohydrate (CHO)/day, \<25 gm added sugar/day)

BEHAVIORAL

Time Limited Eating

16-hour fast/8-hour feed for 3 days per week

DEVICE

Continuous Glucose Monitor

CGM (used to monitor adherence and glycemic outcomes without real time feedback)

Sponsors & Collaborators

Principal Investigators

  • Alaina Vidmar, MD · Children's Hospital Los Angeles

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
14 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-01
Primary Completion
2022-01-30
Completion
2022-03-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03954223 on ClinicalTrials.gov